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Journal of Regulatory Compliance

Tiger King and Zoo Auditing

Libby Meadows Associate Editor Loyola University Chicago School of Law, JD 2021 Like many people during this quarantine, the majority of my days are spent switching through different streaming sites trying to find anything entertaining to watch. Towards the end of March Tiger King: Murder, Mayhem and Madness was released on Netflix. It instantly took …
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Prescribing Online with COVID-19

COVID-19 has rapidly changed the healthcare field unlike anything has before. With the continued spread, healthcare providers have started to adopt telehealth as a way to access patients and continue to provide quality care, without breaking their self-isolation. One avenue that has long been closed off for physicians has been online prescribing, but COVID-19 appears to be changing even that.

Action Against Individuals Regarding Fraudulent Genetic Testing

Michael Manganelli Associate Editor Loyola University Chicago School of Law, JD 2021 In October 2019, The Department of Justice (“DOJ”) announced a multi-agency and multi-state coordinated law enforcement action against 35 individuals involved in an alleged $2.1 billion genetic cancer testing scheme. The alleged scheme involved the payment of illegal kickbacks and bribes to medical professionals …
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Revamping America’s Organ Transplant System

 In December of 2019, two new rules were proposed by the federal government to increase the number of organ transplants in the United States. As of July 2019, 113,000 Americans sat on the national transplant waiting list. The first proposed rule would change the way Organ Procurement Organizations (“OPO”) report data on the number of organs procured. The second proposed rule creates new legislation to assist living donors after their transplant procedures. Both rules were proposed by the Health and Human Services Department (“HHS”) as a follow up to President Trump’s Executive Order on Advancing American Kidney Health.

Stark and Anti-Kickback Statute Get Modern Updates to Account for Value-Based Arrangements

On October 17, 2019, the U.S. Department of Health and Human Services (HHS) published two proposed rules in the Federal Register that could potentially transform key federal laws restricting health care arrangements. These rules address perceived or actual barriers to care coordination and value-based care under Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty (“CMP”) law. The proposals are intended to “modernize and clarify” the regulations that implement and interpret these laws in order to drive innovation and more towards a more affordable health care delivery and payment system, while also maintaining barriers to prevent fraud and abuse. The proposed rules “will improve outcomes by moving away from the old modes of inpatient hospitalizations.”

Should Gift Cards Include Braille in Order to Comply with Title III of the ADA?

Over the past year, restaurants and retailers have had to improve access to their physical locations, websites, and mobile applications to ensure that they are accessible to all individuals and comply with the Americans with Disabilities Act (ADA). Now, restaurants and retailers may have another issue that they need to grapple with in order to comply with the ADA – including braille on gift cards.  

FDA Issues Warnings Regarding E-Cigarettes

On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.

Safeguarding Your Face: Regulating Facial Recognition Technologies

The use of facial recognition technology in the commercial context generates numerous consumer privacy concerns. As technology becomes increasingly present in many aspects of our life, regulations on states and federal level are struggling to catch up. Currently, only three states (Illinois, Washington, and Texas) implemented biometric privacy laws, and only Illinois grants individuals with a private right of action.

HIPAA And The Growth Of Technology

Earlier in 2019, a lawsuit was filed against University of Chicago Medicine, University of Chicago Medical Center, and Google. The suit claims that patient information was shared with google as part of a study aimed to advance the use of Artificial Intelligence, however, patient authorization was not obtained and the data used was not properly de-identified. In 2017, University of Chicago (UChicago) Medicine started sending patient data to Google as part of a project to look to see if historical health record data could be used to predict future medical events.

Recent Movements in Biometric Data Privacy

In 2008, the Illinois legislature introduced and passed the Biometric Information Privacy Act (BIPA), which became the first law of its kind in the US. BIPA was passed to protect individuals against the unlawful collection and storing of biometric information. While many states have enacted similar laws, BIPA remains the most stringent among its contemporaries.